Quality testing methods for the purification of bioactive substances

Abstract

The present invention discloses a quality detection method for purifying bioactive substances, and relates to the field of biotechnology. It is used to solve the problem that researchers with limited experimental conditions cannot quickly and efficiently detect the quality of purified bioactive substances. By analyzing the temperature sensitivity value and acid-base sensitivity value of the raw materials corresponding to the bioactive substances, not only can the purity of the raw materials of the bioactive substances be understood, but also the stability of the raw materials of the bioactive substances at different temperatures and different acid-base values ​​can be quickly and accurately determined, which can help researchers determine the most suitable purification conditions and improve the purification efficiency. According to the image of the purified bioactive substances, it is analyzed to determine whether its purity meets the requirements and the quality control level of the purified bioactive substances is analyzed, which helps researchers quickly understand the quality level of the purified bioactive substances and formulate specific uses according to the quality control level of the purified bioactive substances.

Description

Technical Field

[0001] The present invention relates to the field of biotechnology, in particular to a quality detection method for purifying biologically active substances. Background Art

[0002] Bioactive substances refer to chemical substances that have certain effects or functions on organisms. These chemical substances can be natural products. Bioactive substances can interact specifically with biological molecules in the body, thereby triggering a series of biological effects. Bioactive substances have important application value in the fields of drug development, natural product research, and food additive development. By researching and developing bioactive substances, we can explore new treatments, develop new drugs, and improve food quality.

[0003] The importance of purifying bioactive substances lies in obtaining high-purity substances for in-depth research and application. For the current quality testing of purified bioactive substances, a large number of professional instruments are needed to test the quality of purified bioactive substances. For researchers with limited experimental conditions, there is no way to achieve rapid and efficient quality testing of purified bioactive substances. It is also necessary to further determine the applicability of purified bioactive substances, which increases the burden on researchers. Summary of the invention

[0004] The object of the present invention is to provide a quality detection method for purification of biologically active substances to solve the problems raised by the above-mentioned background technology.

[0005] The object of the present invention can be achieved by the following technical solution: A quality detection method for purification of biologically active substances comprises the following steps:

[0006] W1. Randomly sample the raw materials for purification of biologically active substances, record the raw materials for purification of biologically active substances after random sampling as samples, and after the samples are respectively placed at a preset first temperature and a second temperature for a preset observation time, process and analyze the samples to obtain the temperature sensitivity value of the raw materials;

[0007] W2. Dissolve the sample in a solution with different pH values, and determine the dissolution state of the sample in each solution as a fully dissolved state or a non-fully dissolved state according to the dissolution process of the sample in each solution. When the dissolution state of the sample in a certain solution is a fully dissolved state, the dissolution rate of the sample in the solution and the weight of the solution are analyzed to obtain the acid-base sensitivity index of the sample corresponding to the solution. When the dissolution state of the sample in a certain solution is a non-fully dissolved state, the area and solubility of the insoluble matter in the solution image are analyzed to obtain the acid-base sensitivity index of the sample corresponding to the solution. The acid-base sensitivity index of the sample in each solution is matched with the reference acid-base sensitivity index interval of each solution to obtain each matching solution, and the number of each matching solution is analyzed to obtain the acid-base sensitivity value of the raw material;

[0008] W3. Spread the purified bioactive substance on a collection plate, collect an image of the collection plate and count the number of pixels of the collection plate image, obtain the chromaticity value of each pixel in the collection plate image, compare the chromaticity value of each pixel in the collection plate image with a preset chromaticity value interval one by one, when the chromaticity value of a certain pixel belongs to the standard chromaticity value interval, record the pixel as a target pixel, count the number of target pixels, further compare the grayscale values ​​of the target pixels, when the grayscale value of a certain target pixel belongs to the standard grayscale value interval, record the target pixel as an expected pixel, count the number of expected pixels, and further analyze to obtain the purification value of the purified bioactive substance;

[0009] W4. Based on the temperature sensitivity value, acid-base sensitivity value of the raw materials corresponding to the purification of bioactive substances and the purification value of the purified bioactive substances, the quality control value of the purified bioactive substances is obtained. According to the quality control value, the purified bioactive substances are graded to obtain the various quality control grades of the purified bioactive substances.

[0010] Preferably, the sample is processed and analyzed to obtain the temperature sensitivity value of the raw material, and the analysis process is as follows:

[0011] Randomly sampling raw materials corresponding to the purification of biologically active substances according to a preset collection weight, recording the raw materials purified from the biologically active substances after random sampling as samples, and allowing the samples to stand at preset first temperatures and second temperatures for preset observation times;

[0012] Obtain the average diameter corresponding to the raw material for purification of the biologically active substance from the database, record the samples after standing for observation time at the first temperature and the second temperature as the first temperature sample and the second temperature sample respectively, select a sieve plate with a sieve hole equal to the average diameter corresponding to the raw material for purification of the biologically active substance, sieve the first temperature sample and the second temperature sample respectively to obtain the filter residue of the first temperature sample and the filter residue of the second temperature sample, weigh the filter residue of the first temperature sample and the filter residue of the second temperature sample respectively, and record the weights as ZG1 and ZG2 respectively;

[0013] The agglomerated blocky substances in the filter residues corresponding to the first temperature sample and the second temperature sample are called agglomerates, and a filter membrane with a pore size equal to the preset agglomerate diameter is selected to filter the filter residues corresponding to the first temperature sample and the second temperature sample to obtain the agglomerates of the first temperature sample and the agglomerates of the second temperature sample, and the agglomerates of the first temperature sample and the agglomerates of the second temperature sample are weighed respectively and recorded as TG1 and TG2 respectively;

[0014] The agglomerates of the first temperature sample and the agglomerates of the second temperature sample are dried respectively, and the weights of the agglomerates of the temperature samples are collected in real time. When the weights of the agglomerates of the first temperature sample and the second temperature sample no longer change, the drying is stopped, and the corresponding weights of the agglomerates of the first temperature sample and the second temperature sample are recorded and recorded as HG1 and HG2 respectively;

[0015] The dried lumps of samples at each temperature were placed in a solution that was insoluble in the samples, and the volumes of the lumps of the first temperature sample and the second temperature sample were measured by liquid displacement method. The temperature sensitivity value MG of the raw material corresponding to the purification of the bioactive substance was further analyzed.

[0016] Preferably, the amount of each matching solution is analyzed to obtain the acid-base sensitivity value of the raw material, and the analysis process is as follows:

[0017] Step 1: Obtain the weight of the raw material corresponding to the purification of the bioactive substance required for each solution to reach a saturated state from the database, slowly add the corresponding sample of equal weight to each solution, slowly add the sample to each solution and observe the dissolution process of the sample in each solution;

[0018] Step 2: If the sample is completely dissolved in a certain dissolving solution, the dissolving state of the dissolving solution is determined to be a fully dissolved state, the initial time T when the sample is put into the dissolving solution is obtained, the time when the state of the dissolving solution reaches the fully dissolved state is recorded as the fully dissolved time t, the weight g of the raw material corresponding to the purification of the bioactive substance required for the dissolving solution to reach the saturated state is extracted, the weight of the dissolving solution in the fully dissolved state is recorded as RJg, and the acid-base sensitivity index SJ of the sample corresponding to the dissolving solution is further analyzed;

[0019] Step 3: If the sample is not completely dissolved in a certain solution, the solution is judged to be in a non-completely dissolved state, and an image of the solution is collected using a high-definition camera. The captured solution image is evenly divided into a first-layer solution image, a second-layer solution image, and a third-layer solution image according to the area. The area of ​​the insoluble matter in each layer of the solution image is counted and recorded as S1, S2, and S3, respectively. The solution is filtered using filter paper, and the filter residue on the filter paper is weighed after drying the filtered filter paper and recorded as lzg. Further analysis is performed to obtain the acid-base sensitivity index of the sample corresponding to the solution.

[0020] According to step 1, step 2 and step 3, the acid-base sensitivity index of the sample in each dissolving solution is counted, and the acid-base sensitivity index of the sample in each dissolving solution is matched with the set reference acid-base sensitivity index interval of each dissolving solution. When the acid-base sensitivity index of the sample in a certain dissolving solution is in its corresponding reference acid-base sensitivity index interval, the dissolving solution is recorded as a matching dissolving solution, the number of matching dissolving solutions is counted and recorded as N, and the acid-base sensitivity value mg of the raw material is obtained based on the number of matching solutions;

[0021] Preferably, the purification value of the purified bioactive substance is obtained based on the number of target pixels and the gray value of the target pixels, and the analysis process is as follows:

[0022] The purified bioactive substance is placed on a collection plate, and the image of the collection plate is collected by a high-definition camera. The number of pixels in the collection plate image is counted and recorded as X. The standard chromaticity value interval for purification of the bioactive substance and the reference chromaticity value interval of the collection plate are obtained from the database, and the chromaticity value of each pixel in the collection plate image is obtained. The chromaticity value of each pixel in the collection plate image is compared with the standard chromaticity value interval for purification of the bioactive substance and the reference chromaticity value interval of the collection plate one by one. When the chromaticity value of a certain pixel is in the standard chromaticity value interval for purification of the bioactive substance, the pixel is marked as a target pixel. When the chromaticity value of a certain pixel is in the chromaticity value interval of the collection plate, the pixel is marked as a collection plate pixel. The number of target pixels is counted as XS;

[0023] The grayscale value of each target pixel is obtained, and the grayscale value of each target pixel is compared with the preset grayscale value interval one by one. If a target pixel is in the preset grayscale value interval, the target pixel is marked as an expected pixel, and the number of expected pixels QW is counted. Based on the number of target pixels and the number of expected pixels, the purification value ch of the purified bioactive substance is obtained by analysis.

[0024] Preferably, the purified biologically active substances are graded according to the quality control values ​​to obtain the various quality control grades of the purified biologically active substances, and the classification process is as follows:

[0025] Obtain the temperature sensitivity value, acid-base sensitivity value and purification value of the raw materials corresponding to the purification of the bioactive substance, and the purification value of the purified bioactive substance, and calculate the quality control value of the purified bioactive substance according to the formula CH=MG*p1+mg*p2+ch*p3, p1, p2 and p3 are respectively the preset temperature sensitivity value conversion factor, acid-base sensitivity value conversion factor and purification value conversion factor, and the first quality control value, the second quality control value and the third quality control value are preset, wherein the first quality control value < the second quality control value < the third quality control value;

[0026] The quality control value of the purified bioactive substance is compared with the preset quality control values. If the quality control value of the purified bioactive substance is less than the first quality control value, the quality control grade of the purified bioactive substance is determined to be a third-grade product. If the quality control value of the purified bioactive substance is greater than or equal to the first quality control value and the quality control value of the purified bioactive substance is less than the second quality control value, the quality control grade of the purified bioactive substance is determined to be a second-grade product. If the quality control value of the purified bioactive substance is greater than or equal to the second quality control value and the quality control value of the purified bioactive substance is less than the third quality control value, the quality control grade of the purified bioactive substance is determined to be a first-grade product. If the quality control value of the purified bioactive substance is greater than the third quality control value, the quality control grade of the purified bioactive substance is determined to be a superior product.

[0027] Beneficial effects of the present invention:

[0028] By analyzing the temperature sensitivity and acid-base sensitivity of the raw materials corresponding to the bioactive substances, we can not only understand the purity of the raw materials of the bioactive substances, but also quickly and accurately determine the stability of the raw materials of the bioactive substances at different temperatures and different pH values. This can help researchers determine the most suitable purification conditions and improve the purification efficiency. By analyzing the images of the purified bioactive substances, we can determine whether their purity meets the requirements and analyze the quality control level of the purified bioactive substances. This can help researchers quickly understand the quality level of the substances and formulate specific uses based on the quality control level of the purified bioactive substances. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The present invention will be further described below in conjunction with the accompanying drawings.

[0030] Figure 1 is a flow chart of the steps of this method. DETAILED DESCRIPTION

[0031] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] See also Figure 1 As shown, the present invention is a quality detection method for purification of biologically active substances, comprising the following steps:

[0033] The temperature sensitivity value of the raw materials is analyzed, and the analysis process is as follows:

[0034] Randomly sampling raw materials corresponding to the purification of biologically active substances according to a preset collection weight, recording the raw materials purified from the biologically active substances after random sampling as samples, and allowing the samples to stand at preset first temperatures and second temperatures for preset observation times;

[0035] It should be noted that the physical form of the bioactive substance in the present invention is solid.

[0036] Obtain the average diameter corresponding to the raw material for purification of the biologically active substance from the database, record the samples after standing for observation time at the first temperature and the second temperature as the first temperature sample and the second temperature sample respectively, select a sieve plate with a sieve hole equal to the average diameter corresponding to the raw material for purification of the biologically active substance, sieve the first temperature sample and the second temperature sample respectively to obtain the filter residue of the first temperature sample and the filter residue of the second temperature sample, weigh the filter residue of the first temperature sample and the filter residue of the second temperature sample respectively, and record the weights as ZG1 and ZG2 respectively;

[0037] The agglomerated blocky substances in the filter residues corresponding to the first temperature sample and the second temperature sample are called agglomerates, and a filter membrane with a pore size equal to the preset agglomerate diameter is selected to filter the filter residues corresponding to the first temperature sample and the second temperature sample to obtain the agglomerates of the first temperature sample and the agglomerates of the second temperature sample, and the agglomerates of the first temperature sample and the agglomerates of the second temperature sample are weighed respectively and recorded as TG1 and TG2 respectively;

[0038] The agglomerates of the first temperature sample and the agglomerates of the second temperature sample are dried respectively, and the weights of the agglomerates of the temperature samples are collected in real time. When the weights of the agglomerates of the first temperature sample and the second temperature sample no longer change, the drying is stopped, and the corresponding weights of the agglomerates of the first temperature sample and the second temperature sample are recorded and recorded as HG1 and HG2 respectively;

[0039] The dried lumps of the samples at each temperature are placed in a solution that is insoluble in the sample, and the volumes V1 and V2 of the lumps of the first temperature sample and the second temperature sample are measured by the liquid displacement method. According to the formula:

[0040]

[0041] The temperature sensitivity value of the raw material corresponding to the purification of the bioactive substance is calculated, a1 is the preset filter residue weight weight factor, a2 is the moisture content weight factor, a3 is the agglomerate volume weight factor, G is the preset collection weight, and v is the preset agglomerate volume threshold.

[0042] The present invention analyzes the weight of insoluble matter, the weight of agglomerates and the moisture content of agglomerates of the raw materials of the biologically active substances at different temperatures, can optimize the dissolution conditions and production processes of the raw materials corresponding to the biologically active substances, predict the drug delivery and release behavior, improve the solubility and stability of the biologically active substances, help improve the quality and efficacy of the products, and provide a basis for drug research and development and preparation.

[0043] The acid-base sensitivity of the raw materials is analyzed, and the analysis process is as follows:

[0044] Obtain the weight of the raw material corresponding to the purification of the bioactive substance required for each solution to reach a saturated state from the database, slowly add the corresponding sample of equal weight to each solution, slowly add the sample to each solution and observe the dissolution process of the sample in each solution;

[0045] It should be noted that the quality of the solution at each pH value is consistent.

[0046] If the sample is completely dissolved in a certain solution, it means that the sample has high purity and does not contain impurities. The solution is judged to be in a fully dissolved state. The initial time T when the sample is put into the solution is obtained. The time when the solution reaches the fully dissolved state is recorded as the fully dissolved time t. The weight of the raw material corresponding to the biologically active substance purification required for the solution to reach the saturated state is extracted g. The weight of the solution in the fully dissolved state is recorded as RJg. According to the formula The acid-base sensitivity index of the sample corresponding to the dissolving solution is calculated, where W is the initial weight of the dissolving solution, b1 is the preset dissolving solution weight factor, and b2 is the preset dissolution rate weight factor;

[0047] If the sample is not completely dissolved in a certain solution, the solution is judged to be in a non-completely dissolved state, which means that the solution has reached a saturated state or there are impurities in the sample. The image of the solution is collected using a high-definition camera, and the captured solution image is evenly divided into a first-layer solution image, a second-layer solution image, and a third-layer solution image according to the area. The area of ​​the insoluble matter in each layer of the solution image is counted and recorded as S1, S2, and S3 respectively;

[0048] The dissolved solution is filtered using filter paper, and the filter paper is dried and the filter residue on the filter paper is weighed and recorded as l zg. According to the formula:

[0049]

[0050] The acid-base sensitivity index of the sample corresponding to the dissolving solution is calculated, S is the area of ​​the dissolving solution image, W is the mass of the dissolving solution, c1, c2 and c3 are the preset first area weight factor, second area weight factor and third area weight factor, and c4 is the preset solubility weight factor;

[0051] According to the three steps, the acid-base sensitivity index of the sample in each dissolving solution is repeatedly determined and counted, and the acid-base sensitivity index of the sample in each dissolving solution is matched with the reference acid-base sensitivity index interval of each dissolving solution. When the acid-base sensitivity index of the sample in a certain dissolving solution is in its corresponding reference acid-base sensitivity index interval, the dissolving solution is recorded as a matching dissolving solution, and the number of matching dissolving solutions is counted and recorded as N. The acid-base sensitivity value of the raw material is calculated by the formula mg=N / n;

[0052] The present invention can predict the stability of the raw materials of the bioactive substance under different acid-base environments by analyzing the dissolution state of the raw materials of the bioactive substance under different pH values, which is helpful to formulate appropriate storage and use conditions and ensure the stability and effectiveness of the bioactive substance.

[0053] Furthermore, the present invention helps researchers quickly understand the temperature sensitivity and acid-base sensitivity of the raw materials corresponding to the biologically active substances by analyzing the temperature sensitivity index and acid-base sensitivity index of the raw materials corresponding to the biologically active substances, and can help determine the most suitable purification conditions to improve the purification efficiency. By adjusting the temperature and acid-base conditions, the dissolution, separation and purification of the substances can be promoted, which helps to reduce the generation of by-products and improve the purity and yield of the products.

[0054] The purification value of the purified bioactive substance is analyzed, and the analysis process is as follows:

[0055] The purified bioactive substance is placed on a collection plate, and the image of the collection plate is collected by a high-definition camera. The number of pixels in the collection plate image is counted and recorded as X. The standard chromaticity value interval for purification of the bioactive substance and the reference chromaticity value interval of the collection plate are obtained from the database, and the chromaticity value of each pixel in the collection plate image is obtained. The chromaticity value of each pixel in the collection plate image is compared with the standard chromaticity value interval for purification of the bioactive substance and the reference chromaticity value interval of the collection plate one by one. When the chromaticity value of a certain pixel is in the standard chromaticity value interval for purification of the bioactive substance, the pixel is marked as a target pixel. When the chromaticity value of a certain pixel is in the chromaticity value interval of the collection plate, the pixel is marked as a collection plate pixel. The number of target pixels is counted as XS;

[0056] Get the grayscale value of each target pixel, compare the grayscale value of each target pixel with the preset grayscale value interval one by one, if a target pixel is in the preset grayscale value interval, mark the target pixel as the expected pixel, count the number of expected pixels QW, through the formula:

[0057]

[0058] The purification value of the purified bioactive substance is calculated, where μ2 is the preset target pixel weight factor and μ2 is the preset expected pixel weight factor. The larger the purification value, the higher the purity of the purified bioactive substance.

[0059] The present invention defines the expected color and grayscale range of the purified bioactive substance by presetting the standard chromaticity value interval and grayscale value interval for the purification of the bioactive substance. If the chromaticity value and grayscale value of most pixels are within the preset interval, it means that the color and grayscale of the purified bioactive substance meet the expectations and the purity is high, and the purity of the purified bioactive substance can be reliably judged.

[0060] The purified bioactive substances are graded according to the quality control values. The classification process is as follows:

[0061] Obtain the temperature sensitivity value, acid-base sensitivity value and purification value of the raw materials corresponding to the purification of the bioactive substance, and the purification value of the purified bioactive substance, and calculate the quality control value of the purified bioactive substance according to the formula CH=MG*p1+mg*p2+ch*p3, p1, p2 and p3 are respectively the preset temperature sensitivity value conversion factor, acid-base sensitivity value conversion factor and purification value conversion factor, and the first quality control value, the second quality control value and the third quality control value are preset, wherein the first quality control value < the second quality control value < the third quality control value;

[0062] The quality control value of the purified bioactive substance is compared with the preset quality control values. If the quality control value of the purified bioactive substance is less than the first quality control value, the quality control grade of the purified bioactive substance is determined to be the third-grade product, indicating that the quality of the purified bioactive substance is very poor, there may be many impurities, the biological activity is very low, and it is not suitable for testing or direct disposal. If the quality control value of the purified bioactive substance is greater than or equal to the first quality control value and the quality control value of the purified bioactive substance is less than the second quality control value, the quality control grade of the purified bioactive substance is determined to be the second-grade product, indicating that the quality of the purified bioactive substance is general, the biological activity is low, and it can be used for preliminary exploratory Research, if the quality control value of the purified bioactive substance is greater than or equal to the second quality control value and the quality control value of the purified bioactive substance is less than the third quality control value, then the quality control grade of the purified bioactive substance is determined to be first-class, indicating that the purified bioactive substance is of good quality and high purity, with only some slight impurities, and can be suitable for preliminary research and reference; if the quality control value of the purified bioactive substance is greater than the third quality control value, then the quality control grade of the purified bioactive substance is determined to be superior, indicating that the purified bioactive substance is of excellent quality, high purity, basically no impurities, has high biological activity, and can be used as an ideal candidate for drug development or other applications.

[0063] The present invention divides the quality control levels of the purified bioactive substances, which makes it convenient for researchers to formulate specific uses according to the quality control levels of the purified bioactive substances. The quality level of the substances can be quickly understood, which helps to decide whether to use the purified bioactive substances for further research or application, thereby significantly improving the selectivity and applicability of the purified bioactive substances.

[0064] The above contents are merely examples and explanations of the structure of the present invention. The technical personnel in the relevant technical field may make various modifications or additions to the specific embodiments described or replace them in a similar manner. As long as they do not deviate from the structure of the invention or exceed the scope defined by the claims, they should all fall within the protection scope of the present invention.

Claims

1. A quality detection method for purification of biologically active substances, characterized in that: The following steps are involved: W1. Randomly sample the raw materials for purification of biologically active substances, record the raw materials for purification of biologically active substances after random sampling as samples, and after the samples are respectively placed at a preset first temperature and a second temperature for a preset observation time, process and analyze the samples to obtain the temperature sensitivity value of the raw materials; The analysis comprises: placing the dried lumps of the samples at each temperature into a solution that is insoluble in the sample, measuring the volumes of the lumps of the first temperature sample and the second temperature sample by a liquid displacement method, and further analyzing to obtain the temperature sensitivity value of the raw material corresponding to the purification of the bioactive substance; the lumps are block-shaped substances that are agglomerated in the filter residues corresponding to the first temperature sample and the second temperature sample; W2. Dissolve the sample in a solution with different pH values, determine the dissolution state of the sample in each solution as a fully dissolved state or a non-fully dissolved state according to the dissolution process of the sample in each solution, analyze the acid-base sensitivity index of each solution according to the dissolution state, and analyze the number of matching solutions based on the acid-base sensitivity index to obtain the acid-base sensitivity value of the raw material; W3. Spread the purified bioactive substance on a collection plate, collect an image of the collection plate and count the number of pixels of the collection plate image, obtain the chromaticity value of each pixel in the collection plate image, compare the chromaticity value of each pixel in the collection plate image with a preset chromaticity value interval one by one to obtain each target pixel, and obtain the purification value of the purified bioactive substance based on the number of target pixels and the gray value of the target pixels; W4. Based on the temperature sensitivity value, acid-base sensitivity value of the raw materials corresponding to the purification of the bioactive substances and the purification value of the purified bioactive substances, the quality control value of the purified bioactive substances is obtained. According to the quality control value, the purified bioactive substances are graded to obtain various quality control grades of the purified bioactive substances.

2. The quality detection method for purification of biologically active substances according to claim 1, characterized in that: The sample is processed and analyzed to obtain the temperature sensitivity value of the raw material, and the analysis process is as follows: Randomly sampling raw materials corresponding to the purification of biologically active substances according to a preset collection weight, recording the raw materials purified from the biologically active substances after random sampling as samples, and allowing the samples to stand at preset first temperatures and second temperatures for preset observation times; Obtain the average diameter corresponding to the raw material for purification of the biologically active substance from the database, record the samples after standing for observation at the first temperature and the second temperature as the first temperature sample and the second temperature sample respectively, select a sieve plate with a sieve hole equal to the average diameter corresponding to the raw material for purification of the biologically active substance, sieve the first temperature sample and the second temperature sample respectively to obtain the filter residue of the first temperature sample and the filter residue of the second temperature sample, and weigh the filter residue of the first temperature sample and the filter residue of the second temperature sample respectively; The agglomerated blocky substances in the filter residues corresponding to the first temperature sample and the second temperature sample are called agglomerates, and a filter membrane with a pore size equal to a preset agglomerate diameter is selected to filter the filter residues corresponding to the first temperature sample and the second temperature sample to obtain the agglomerates of the first temperature sample and the agglomerates of the second temperature sample, and the agglomerates of the first temperature sample and the agglomerates of the second temperature sample are weighed respectively; The agglomerates of the first temperature sample and the agglomerates of the second temperature sample are dried respectively, and the weight of the agglomerates of each temperature sample is collected in real time. When the weight of the agglomerates of the first temperature sample and the second temperature sample no longer changes, the drying is stopped, and the corresponding weights of the agglomerates of the first temperature sample and the second temperature sample are recorded; The dried lumps of samples at each temperature were placed in a solution that was insoluble in the samples, and the volumes of the lumps of the first temperature sample and the second temperature sample were measured by liquid displacement method. The temperature sensitivity values ​​of the raw materials corresponding to the purification of bioactive substances were further analyzed.

3. The quality detection method for purification of biologically active substances according to claim 1, characterized in that: The amount of each matching solution is analyzed to obtain the acid-base sensitivity value of the raw material, and the analysis process is as follows: Step 1: Obtain the weight of the raw material corresponding to the purification of the bioactive substance required for each solution to reach a saturated state from the database, slowly add the corresponding sample of equal weight to each solution, slowly add the sample to each solution and observe the dissolution process of the sample in each solution; Step 2: if the sample is completely dissolved in a certain dissolving solution, the dissolving state of the dissolving solution is determined to be a fully dissolved state, the initial time when the sample is put into the dissolving solution is obtained, the time when the state of the dissolving solution reaches the fully dissolved state is recorded as the fully dissolved time, the weight of the raw material corresponding to the purification of the bioactive substance required for the dissolving solution to reach a saturated state is extracted, and the acid-base sensitivity index of the sample corresponding to the dissolving solution is further analyzed; Step 3: If the sample is not completely dissolved in a certain solution, the solution is judged to be in a non-completely dissolved state, and an image of the solution is collected using a high-definition camera. The captured solution image is evenly divided into a first layer solution image, a second layer solution image, and a third layer solution image according to the area, and the area of ​​the insoluble matter in each layer of the solution image is counted. The solution is filtered using filter paper, and the filter residue on the filter paper is weighed after drying the filtered filter paper, and the acid-base sensitivity index of the sample corresponding to the solution is further analyzed; According to step one, step two and step three, the acid-base sensitivity index of the sample in each dissolving solution is counted, and the acid-base sensitivity index of the sample in each dissolving solution is matched with the set reference acid-base sensitivity index interval of each dissolving solution. When the acid-base sensitivity index of the sample in a certain dissolving solution is in its corresponding reference acid-base sensitivity index interval, the dissolving solution is recorded as a matching dissolving solution, the number of matching dissolving solutions is counted, and the acid-base sensitivity value of the raw material is obtained based on the number of matching solutions.

4. The quality detection method for purification of biologically active substances according to claim 1, characterized in that: The purification value of the purified bioactive substance is obtained by analyzing the number of target pixels and the gray value of the target pixels. The analysis process is as follows: The purified bioactive substance is placed on a collection plate, and the image of the collection plate is collected by a high-definition camera, and the number of pixels in the collection plate image is counted, and the standard chromaticity value interval for purification of the bioactive substance and the reference chromaticity value interval of the collection plate are obtained from a database, and the chromaticity value of each pixel in the collection plate image is obtained, and the chromaticity value of each pixel in the collection plate image is compared with the standard chromaticity value interval for purification of the bioactive substance and the reference chromaticity value interval of the collection plate respectively. When the chromaticity value of a certain pixel is in the standard chromaticity value interval for purification of the bioactive substance, the pixel is marked as a target pixel, and when the chromaticity value of a certain pixel is in the chromaticity value interval of the collection plate, the pixel is marked as a collection plate pixel, and the number of target pixels is counted; The grayscale value of each target pixel is obtained, and the grayscale value of each target pixel is compared with the preset grayscale value interval one by one. If a target pixel is in the preset grayscale value interval, the target pixel is marked as an expected pixel, and the number of expected pixels is counted. The purification value of the purified bioactive substance is obtained based on the number of target pixels and the number of expected pixels.

5. The quality detection method for purification of biologically active substances according to claim 1, characterized in that: The purified bioactive substances are graded according to the quality control values ​​to obtain the various quality control grades of the purified bioactive substances. The classification process is as follows: Obtaining the temperature sensitivity value, acid-base sensitivity value of the raw materials corresponding to the purification of the bioactive substance and the purification value of the purified bioactive substance, further analyzing to obtain the quality control value of the purified bioactive substance, and presetting the first quality control value, the second quality control value and the third quality control value; The quality control value of the purified bioactive substance is compared with the preset quality control values, and the quality control level of the purified bioactive substance is divided into third-grade, second-grade, first-grade and superior grade according to the comparison results.

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